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Biowaivers: Practical and Regulatory Approaches

4-week online academy | 2 hours per week

1 - 29 June 2020

Online Academy

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Examine key regulatory and data requirements for the practical application of biowaivers in the EU and US

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A biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for approval). As a result, they represent a useful and cost-effective alternative to performing in vivo studies for generic drugs, however they can be challenging to get right first time.

This course will improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks, using case studies and practical guidance. By examining the requirements for BCS-based, Strength and IVIVC biowaivers, you will have the confidence and skills to implement a strategic approach for new product registrations.

Introduction to biopharmacy
Understand the legal basis for biowaivers
Investigate BCS biowaivers
Explore strength biowaivers
Understand dissolution data to be submitted
Consider applications of IVIVC biowaivers
Learn about and compare US-FDA and EMA regulations

Jean-Michel Cardot is a professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. His laboratory research fields are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and IVIVC.

This course is designed for professionals involved in the development/ registration of generic products. Attendees may work in the following areas:

Regulatory Affairs
Pharmaceutical Development
Analytical Development
IVIVC
R&D for generics

What is an Online Academy course?
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.

Over 4 weeks students will learn through:

8 modules, split up into multiple bitesize recorded videos
Quizzes to test your knowledge
Revisit the content with unlimited access to all the materials for 2 months
Access the discussion forum and interact with other students and the trainer
Direct contact with the trainer through the forum during the 4 weeks the course is running
Additional content such as slides and white papers available to download

Watch the Online Academy Video

On average, delegates of our online academies said:

What are the benefits of an Online Academy?

Access the course here

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores how to optimise IVIVC using your dissolution data.

Topics covered:

Basis of IVIVC
Why IVIVC and dissolution are important
Use in development: interest and limitations
Optimisation of formulation based on IVIVC
Conclusions and Q&A session

Testimonials about the course leader:

The trainer was very experienced with many examples and encouraged time for questions.

Regulatory Affairs International Project Manager, Medac GmbH

The trainer was very knowledgeable and had good presentation skills.

Director, Northumbria Pharma

The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.

Biowaivers: Practical and Regulatory Approaches

4-week online academy | 2 hours per week

1 - 29 June 2020

Online Academy

Examine key regulatory and data requirements for the practical application of biowaivers in the EU and US

Watch the Online Academy Video

On average, delegates of our online academies said:

What are the benefits of an Online Academy?

Access the course here

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

Testimonials about the course leader:

The trainer was very experienced with many examples and encouraged time for questions.

The trainer was very knowledgeable and had good presentation skills.

Director, Northumbria Pharma

The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.

Regulatory Affairs Development Manager, Regivet BV

You may also be interested in...

Examine key regulatory and data requirements for the practical application of biowaivers in the EU and US

Watch the Online Academy Video

On average, delegates of our online academies said:

What are the benefits of an Online Academy?

Access the course here

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

Testimonials about the course leader:

The trainer was very experienced with many examples and encouraged time for questions.

The trainer was very knowledgeable and had good presentation skills.

Director, Northumbria Pharma

The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.

Regulatory Affairs Development Manager, Regivet BV

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